As the novel coronavirus (COVID-19) crisis continues to present new questions and challenges, the U.S. Food and Drug Administration (FDA) continues to update its website to provide additional information and guidance to the food industry. Since FDA initially issued guidance last week, the agency has supplemented this guidance with six additional questions and answers concerning important issues such as continuing operations in the event that an employee tests positive for COVID-19 and how to maintain social distancing in food production/processing facilities and food retail establishments. FDA continues to emphasize that COVID-19 does not pose a food safety risk. Below we provide the key takeaways from each of the new questions and answers.

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In our memo of March 19, we summarized federal government policy identifying the Food and Agriculture and Transportation industries as two of the nation’s 16 Critical Infrastructure Sectors. In The President’s Coronavirus Guidelines for America, the government emphasizes that “If you work in a critical infrastructure industry . . . such as . . . food supply, you have a special responsibility to maintain your normal work schedule.” On the afternoon of March 19, the Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) released guidance identifying more specifically the type of food and agriculture sector workers that should be exempted from state and local shelter in place orders, curfews, and similar restrictions on movement. Although not binding on state and local authorities, the CISA guidance provides a central reference point likely to be instructive as states and localities implement movement restrictions.

Please see our March 19 memo for considerations in managing operations during movement restrictions, including template certification letters for affected workers.

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Late yesterday, the U.S. Food and Drug Administration (FDA) announced that due to the COVID-19 pandemic the agency has temporarily postponed all domestic routine surveillance facility inspections.

This announcement is not limited to the food industry, but the impacts for the food industry are the focus of this memorandum. FDA is taking this action for the health and well-being of inspection personnel and because of industry concerns about visitors. FDA will continue to conduct domestic for-cause inspections if they are determined to be mission-critical. This announcement was preceded by a Stakeholder conference call FDA held directed specifically to the food industry. This blog provides FDA’s official statement, along with feedback from the Stakeholder call, and summarizes the key takeaways regarding FDA’s new policy.

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As the novel coronavirus crisis continues to escalate, state and local governments have begun implementing increasingly aggressive measures, including restrictions on when and which businesses may operate, quarantines, curfews, and lockdowns. Some measures have been tailored to accommodate the continued operation of the food sector, while others are more general. These restrictions risk creating confusion as to whether food sector employees may travel to work or conduct transportation operations during restricted time periods, and companies should expect more such measures in the coming days.

This alert summarizes federal government policy prioritizing the continued operation of the food and agriculture sector and related transportation operations as Critical Infrastructure Sectors and provides template letters companies may wish to use to identify employees, contractors, and carriers as Critical Industry Infrastructure workers.

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As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the public, and inspectors with guidance concerning food safety and how to respond in the event that food industry personnel test positive for COVID-19. Importantly, FDA does not anticipate that food products would need to be recalled or be withdrawn from the market when a food employee tests positive for COVID-19 because there is currently no evidence to support the transmission of COVID-19 associated with food or food packaging. Similarly, USDA says that it is not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging.

This blog summarizes key takeaways in the following agency documents and communications:

  • FDA’s website on Food Safety and the Coronavirus Disease 2019 (COVID-19);
  • FDA’s temporary policy on onsite audits under the Food Safety Modernization Act (FSMA) regulations;
  • USDA’s COVID-19 Questions & Answers (Q&As);
  • USDA communications concerning Food Safety and Inspection Service (FSIS) and Agricultural Marketing Service (AMS) inspectional issues.

While this blog is focused on the guidance from federal agencies, state and local jurisdictions also are starting to issue their own guidance documents, and there are existing reporting requirements in some jurisdictions. Food companies will need to take account of federal, state, and local requirements and guidance when addressing this quickly evolving situation.

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As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has been declared a public health emergency. At this time there have been no reported concerns of COVID-19 transmission via food or food packaging, according to FDA. Nonetheless, we are receiving many inquiries. We are issuing this memorandum to summarize key public health advice and to highlight some key issues to consider when developing a communicable disease response strategy.

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The U.S. Food and Drug Administration (FDA) announced that it is reopening the comment period on a 2005 proposed rule to establish a set of general principles to use when considering whether to establish, revise, or eliminate a food standard of identity (SOI). 1/ The 2005 proposed rule adopted the approach of elaborating a set of 13 general principles (listed in Appendix 1 below) that would shape FDA’s consideration of petitions to establish, revise, or eliminate standards. This approach to modernizing SOIs relies on industry and other groups to draft petitions consistent with the general principles for the agency to review in making standards determinations. FDA is seeking new information and public comment on its proposal to create general principles for establishing new food standards and for revising or eliminating existing food standards. Written comments are due by April 21, 2020 and can be submitted to the Federal Register docket number FDA-1995-N-0062.

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The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule). Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan (or FDP) that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working.

FDA released the first four chapters of the Draft Guidance in June 2018. Those chapters (1) provided templates for various components of a food defense plan, (2) addressed how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps (the Key Activity Type (KAT) method), and (3) included information regarding mitigation strategies for actionable process steps and monitoring. The second installment of the Draft Guidance provided new content addressing an alternative vulnerability assessment approach, which could be more tailored to a facility by using the three factors in the regulation. The installment also provided guidance on training requirements for individuals performing various tasks under the rule.

This last installment of the IA rule Draft Guidance adds to the previous chapters, covering topics focused on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. This memorandum provides an overview of the new material and is by no means a comprehensive summary. We encourage food facilities covered by the IA rule to read the final installment in its entirety.

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Please join us on Wednesday, March 11 for the next webinar in our series – A Seat at the Table – What’s new in food law.

The series features updates on the latest news and trends in the food and beverage industry. This session will focus on updates regarding supply agreements, the new nutritional labeling requirements in Mexico, and the latest trends in food deals. Please see below for the program agenda:

The top five provisions to have in a supply agreement

Meryl Bernstein will outline the reasons why it is critical for food and beverage companies to have contractual arrangements with co-manufacturers or co-packers, and why retailers should have clear supply agreements in place with the providers of products they sell in stores.

New nutritional labeling regulations and requirements in Mexico

Cecilia Stahlhut will discuss the main impacts of the new regulations and the new labeling requirements for companies that sell food products in Mexico.

The latest trends in food deals

John Duke will discuss current deal trends in the food and beverage space including how fast-changing consumer demands continue to drive the M&A market.

Click here to register for this complimentary webinar. 

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